Position Title: Regulatory Affairs Executive
Job Description Summary
The main reason for the job is to regulate and ensure that the company does not violate any local regulatory regulations as well as maintain the Global GSK requirement for its affiliates.
Regulatory Affairs Management maintains the organisation’s on-going relationships with regulatory commissions/authorities relating to clinical issues. Ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Advances organisation positions with internal and external parties. In addition to the line management responsibilities, would be involved in the strategy across therapy areas.
Registration and product licence maintenance for the GSK companies as above
Obtain NAFDAC’S approval for adverts for these companies
Co-ordinating destruction exercises within the company and between the company and NAFDAC for all Pharma products
Participate in company projects from time to time
Monitor and keep in touch with changes in the regulatory environments.
Processing of permits to import and permits to clear for controlled drug products and substances when the need arises
Communicate effectively with the commercial team of any new developments or changes to products or processes.
Ensuring that the premises licences for both GSK Pharmaceutical warehouses were these company products are stored as well as their pharmacists are current for each operating year.
Need to be able to adapt quickly to constantly changing regulatory policies and environment
Ability to plan and organise work
Quick adaptation to continuously increasing responsibilities.
Ability to Lobby and get filing documents to avoid delayed product approvals
Proactively anticipate issues and get them resolve
Use regulatory knowledge to ensure fast product approvals.
Prompt processing of registration of products to support the commercial team in timely product launches
Prompt processing of advert materials to meet up the commercial team for product promotions
Prompt attendance to internal artwork/promotional materials approval process
Collaboration with other Regulatory team to ensure departmental objectives are achieved
Annual Strategic Planning:
This process serves as a guide of what is expected in the next three years from the department and enhances prioritization of product registration.
Proactively work out strategy for prompt approvals in the 3/1 plan process
Bachelor of Pharmacy degree
1-2years Regulatory or work Experience in the industry.
Computer Literate and proficient
Negotaition Skills with Regulators and Internal Customers
Good Communication skills
Good behavioural skills
Sound understanding of basic Regulatory guidelines both locally and internationally.
Enthusiasm of entrepreneurs
Constant search for Innovation
Improved and well channelled lobby strategy
Performance achieved with Integrity
Contributing with Passion and an unmatched sense of urgency
Knowledge of Quality Management System principles and guidelines as it relates to marketing companies in GSK
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